Dietary Reversal of the Reprometabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Urinary Pregnadiol Glucouronide concentration in ug/mg creatinine
研究概览
简要总结
This study proposes to test the specific question that a eucaloric, low-fat diet given to women with obesity will result in an increase in reproductive hormones.
详细描述
This an open-label, multi site study in pre-menopausal women aged 18-40 years old with a history of regular menstrual cycles (25-35 days long) of high BMI. The objective of the study will be to determine the effects of a one month long, eucaloric low-fat diet on reproductive hormone levels in women with a high BMI. The study will occur over 4 menstrual cycle (approximately 4 months). During the study the participants will have a pre-diet cycle where no food will be consumed, an on-diet cycle where the customized low-fat diet will be consumed, and two post diet cycles. First morning voided urine will be collected during all four cycles along with 3 blood draws during the study. Participants will be asked to use a reliable barrier method of birth control or abstain from intercourse during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal TSH and prolactin
- •Regular menstrual cycles every 25-40 days
- •No history of chronic disease affecting hormone production, metabolism or clearance
- •No use of reproductive hormones, or medications/supplements known to impact them, within 3 months of enrollment
- •Use of a reliable method of contraception (female or male partner sterilization, IUD, abstinence, diaphragm or cervical cap)
- •Normal ovarian reserve (AMH of 0.5ng/ml or greater)
- •Normal testosterone levels at screening or absence of clinical evidence of hyperandrogenemia (acne, facial hirsutism [defined as Ferriman-Gallwey score>8] or alopecia)
排除标准
- •Baseline dietary assessment indicative of 28% or less daily calories from fat
- •Inability to comply with the protocol (many meals per week eaten outside of the home, frequent travel)
- •Pregnancy or planned pregnancy within next 6 months at time of screening
- •HbA1C >6.5%
结局指标
主要结局
Urinary Pregnadiol Glucouronide concentration in ug/mg creatinine
时间窗: From enrollment for 4 months post enrollment
次要结局
- Amount of Urinary estrogen(From enrollment to 4 months)